Nicotine Patch and Bupropion to Reduce Smoking Rates in Younger, Low-Income, and Minority Individuals

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had three arms (groups): 1 (active comparator), 2 (active comparator) and 3 (active comparator).

Nicotine patch plus placebo sustained-release bupropion.

Placebo nicotine patch plus sustained-release bupropion.

Nicotine patch plus sustained-release bupropion.

The registry classes the interventions as drug.

More on the Plan

The negative health effects of smoking are well-known, but the prevalence of cigarette smoking remains high in the United States, particularly among younger people, people of lower socioeconomic status, and minority groups.

Bupropion, a medication commonly used to treat depression, is also used as a smoking cessation tool.

It helps to control nicotine cravings.

This 1-year study will enroll younger, low-income, and minority individuals who smoke.

Who Took Part

The registry lists 594 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: In good health. In a lower socioeconomic group, defined as below median income in the study county. Smokes more than 5 cigarettes each day for at least 6 months prior to study entry, as determined by self-report.

The full record lists 3 inclusion and 18 exclusion criteria; among the exclusions: history of a seizure disorder, brain tumor, or severe head trauma; history of substance abuse, including alcohol use in excess of 14 drinks a week; history of anorexia or bulimia.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2004-01 with completion listed for 2008-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Smoking cessation rates (measured by self-report, saliva test, and exhaled carbon monoxide test) (time frame: Measured at 1 year follow-up).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 594 people.

With 594 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.